NCT00306189

Brief Summary

The primary objective of this study is to assess the effect of AMG 162 (denosumab) treatment on the lumbar spine BMD at month 12 and safety profile across the dose range tested (14, 60 and 100 mg SC once every 6 months) in Japanese postmenopausal osteoporotic subjects compared with those treated with placebo over 12 months.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

January 27, 2010

Completed
Last Updated

June 20, 2013

Status Verified

June 1, 2013

Enrollment Period

1.4 years

First QC Date

March 21, 2006

Results QC Date

December 22, 2009

Last Update Submit

June 13, 2013

Conditions

Osteoporosis

Keywords

RANKLRANKdenosumabAMG 162osteoporosisbone turnoverbone mineral densityJapanese

Outcome Measures

Primary Outcomes (1)

  • Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12

    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

    12 months

Study Arms (4)

100 mg AMG 162

ACTIVE COMPARATOR
Drug: 100 mg AMG 162

60 mg AMG 162

ACTIVE COMPARATOR
Drug: 60 mg AMG 162

Placebo

PLACEBO COMPARATOR
Drug: Placebo

14 mg AMG 162

ACTIVE COMPARATOR
Drug: 14 mg AMG 162

Interventions

100 mg AMG 162DRUG

100 mg AMG 162 (denosumab) SC every 6 months

100 mg AMG 162
60 mg AMG 162DRUG

60 mg AMG 162 (denosumab) SC every 6 months

60 mg AMG 162
14 mg AMG 162DRUG

14 mg AMG 162 (denosumab) SC every 6 months

14 mg AMG 162
PlaceboDRUG

Placebo SC every 6 months

Placebo

Eligibility Criteria

AgeUp to 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Nakamura T, Matsumoto T, Sugimoto T, Shiraki M. Dose-response study of denosumab on bone mineral density and bone turnover markers in Japanese postmenopausal women with osteoporosis. Osteoporos Int. 2012 Mar;23(3):1131-40. doi: 10.1007/s00198-011-1786-8. Epub 2011 Sep 17.

    PMID: 21927920RESULT

Related Links

MeSH Terms

Conditions

Osteoporosis

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Study Director
Organization
Amgen Inc.
866-572-6436

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2006

First Posted

March 23, 2006

Study Start

January 1, 2006

Primary Completion

June 1, 2007

Study Completion

November 1, 2007

Last Updated

June 20, 2013

Results First Posted

January 27, 2010

Record last verified: 2013-06